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calendar

9,438 catalysts · 9,438 approval · 5,000 device 510k · 4,728 grant · 2,604 8k filing · 2,000 device pma · 2,000 device recall

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type: approval×from 2017-11-21×clear all
type
  • approval9,438
  • device 510k5,000
  • grant4,728
  • 8k filing2,604
  • device pma2,000
  • device recall2,000
  • recall
1,126
  • device adverse event1,000
  • pdufa347
  • earnings315
  • therapy area

    no tagged catalysts yet

    Week of Nov 20, 2017

    5
    ›Nov 21, 2017approval$BIIB202.95-2.40%3177d agoSPINRAZA (NUSINERSEN SODIUM) — FDA approvalBIOGEN INC.

    Sponsor: BIOGEN IDEC. Form: SOLUTION. Route: INTRATHECAL

    full page →fda approvals ↗
    ›Nov 21, 2017approval3177d agoTRIUMEQ (ABACAVIR SULFATE) — FDA approvalViiV Healthcare Company

    Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2017approval3177d agoTIVICAY (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

    Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 21, 2017approval3177d agoJULUCA (DOLUTEGRAVIR SODIUM) — FDA approvalViiV Healthcare Company

    Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 22, 2017approval3176d agoENBREL (ETANERCEPT) — FDA approvalAMGEN INC

    Sponsor: IMMUNEX. Form: SYRINGE

    full page →fda approvals ↗

    Week of Nov 27, 2017

    8
    ›Nov 27, 2017approval3171d agoCAPECITABINE — FDA approvalArmas Pharmaceuticals Inc

    Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Nov 28, 2017approval

    Week of Dec 4, 2017

    5
    ›Dec 5, 2017approval3163d agoHALDOL (HALOPERIDOL DECANOATE) — FDA approvalJanssen Therapeutics

    Sponsor: JANSSEN PHARMS. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    ›Dec 5, 2017approval

    Week of Dec 11, 2017

    14
    ›Dec 12, 2017approval3156d agoTRULICITY (DULAGLUTIDE) — FDA approvaldulaglutide

    Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION

    full page →dulaglutide →fda approvals ↗
    ›Dec 12, 2017approval

    Week of Dec 18, 2017

    10
    ›Dec 18, 2017approval3150d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 18, 2017approval

    Week of Dec 25, 2017

    7
    ›Dec 26, 2017approval3142d agoFLUOROURACIL — FDA approvalEfudex

    Sponsor: GLAND. Form: INJECTABLE. Route: INJECTION

    full page →Efudex →fda approvals ↗
    ›Dec 26, 2017approval

    Week of Jan 1, 2018

    1
    ›Jan 3, 2018approval3134d agoTROKENDI XR (TOPIRAMATE) — FDA approvalSUPERNUS PHARMACEUTICALS, INC.

    Sponsor: SUPERNUS PHARMS. Form: CAPSULE, EXTENDED RELEASE. Route: ORAL

    full page →fda approvals ↗
    ← prev
    page 1 of 189
    next →
    3170d ago
    VENOFER (IRON SUCROSE) — FDA approvalInternational Medication Systems Ltd

    Sponsor: AM REGENT. Form: INJECTABLE. Route: INTRAVENOUS

    full page →fda approvals ↗
    ›Nov 29, 2017approval3169d agoKEYTRUDA (PEMBROLIZUMAB) — FDA approvalpembrolizumab

    Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

    full page →pembrolizumab →fda approvals ↗
    ›Nov 30, 2017approval3168d agoLANSOPRAZOLE — FDA approvallansoprazole DR

    Sponsor: DEXCEL. Form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE. Route: ORAL

    full page →lansoprazole DR →fda approvals ↗
    ›Nov 30, 2017approval3168d agoLANSOPRAZOLE — FDA approvallansoprazole DR

    Sponsor: DEXCEL. Form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE. Route: ORAL

    full page →lansoprazole DR →fda approvals ↗
    ›Nov 30, 2017approval3168d agoZYPREXA RELPREVV (OLANZAPINE PAMOATE) — FDA approvalCHEPLAPHARM Arzneimittel GmbH

    Sponsor: CHEPLAPHARM. Form: SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

    full page →fda approvals ↗
    ›Nov 30, 2017approval3168d agoSUBLOCADE (BUPRENORPHINE) — FDA approvalbuprenorphine LA

    Sponsor: INDIVIOR. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

    full page →buprenorphine LA →fda approvals ↗
    ›Nov 30, 2017approval3168d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

    Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

    full page →blinatumomab →fda approvals ↗
    3163d ago
    OZEMPIC (SEMAGLUTIDE) — FDA approvalNovo Nordisk AS

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Dec 6, 2017approval3162d agoLACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalCALCIUM CHLORIDE 10%

    Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION

    full page →CALCIUM CHLORIDE 10% →fda approvals ↗
    ›Dec 6, 2017approval3162d agoPOTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER (CALCIUM CHLORIDE) — FDA approvalCALCIUM CHLORIDE 10%

    Sponsor: BAXTER HLTHCARE. Form: INJECTABLE. Route: INJECTION

    full page →CALCIUM CHLORIDE 10% →fda approvals ↗
    ›Dec 8, 2017approval3160d agoBUSULFAN — FDA approvalWoodward Pharma Services LLC

    Sponsor: ACTAVIS. Form: INJECTABLE. Route: INJECTION

    full page →fda approvals ↗
    3156d ago
    XULTOPHY 100/3.6 (INSULIN DEGLUDEC) — FDA approvalNovo Nordisk Inc

    Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS

    full page →fda approvals ↗
    ›Dec 13, 2017approval3155d agoBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

    Sponsor: SPECGX LLC. Form: TABLET. Route: SUBLINGUAL

    full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 13, 2017approval3155d agoSYNJARDY XR (EMPAGLIFLOZIN) — FDA approval(empagliflozin + metformin hydrochloride ER)

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →(empagliflozin + metformin hydrochloride ER) →fda approvals ↗
    ›Dec 13, 2017approval3155d agoGLYXAMBI (EMPAGLIFLOZIN) — FDA approval(empagliflozin + linagliptin)

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

    full page →(empagliflozin + linagliptin) →fda approvals ↗
    ›Dec 13, 2017approval3155d agoSYNJARDY (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

    full page →SYNJARDY →fda approvals ↗
    ›Dec 13, 2017approval3155d agoJARDIANCE (EMPAGLIFLOZIN) — FDA approvalSYNJARDY

    Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL

    full page →SYNJARDY →fda approvals ↗
    ›Dec 13, 2017approval3155d agoIXIFI (INFLIXIMAB-QBTX) — FDA approvalIXIFI

    Sponsor: PFIZER INC. Form: INJECTABLE. Route: INJECTION

    full page →IXIFI →fda approvals ↗
    ›Dec 14, 2017approval3154d agoXELJANZ XR (TOFACITINIB CITRATE) — FDA approvaltofacitinib citrate ER

    Sponsor: PFIZER. Form: TABLET, EXTENDED RELEASE. Route: ORAL

    full page →tofacitinib citrate ER →fda approvals ↗
    ›Dec 14, 2017approval3154d agoXELJANZ (TOFACITINIB CITRATE) — FDA approvalBiocon Pharma Ltd

    Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 14, 2017approval3154d agoHUMIRA (ADALIMUMAB) — FDA approvaladalimumab

    Sponsor: ABBVIE INC. Form: VIAL

    full page →adalimumab →fda approvals ↗
    ›Dec 14, 2017approval3154d agoIMITREX STATDOSE (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    ›Dec 14, 2017approval3154d agoIMITREX (SUMATRIPTAN) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: SPRAY. Route: NASAL

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    ›Dec 14, 2017approval3154d agoIMITREX (SUMATRIPTAN SUCCINATE) — FDA approvalSUMATRIPTAN SUCCINATE

    Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL

    full page →SUMATRIPTAN SUCCINATE →fda approvals ↗
    3150d ago
    HYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

    Sponsor: NOVEL LABS INC. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 19, 2017approval3149d agoBOSULIF (BOSUTINIB MONOHYDRATE) — FDA approvalAlembic Pharmaceuticals Inc

    Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 19, 2017approval3149d agoAUBAGIO (TERIFLUNOMIDE) — FDA approvalteriflunomide

    Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL

    full page →teriflunomide →fda approvals ↗
    ›Dec 19, 2017approval3149d agoCABOMETYX (CABOZANTINIB S-MALATE) — FDA approvalcabozantinib s-malate

    Sponsor: EXELIXIS INC. Form: TABLET. Route: ORAL

    full page →cabozantinib s-malate →fda approvals ↗
    ›Dec 20, 2017approval3148d agoOPDIVO (NIVOLUMAB) — FDA approvalnivolumab

    Sponsor: BRISTOL MYERS SQUIBB. Form: INJECTABLE. Route: INJECTION

    full page →nivolumab →fda approvals ↗
    ›Dec 20, 2017approval3148d agoVENCLEXTA (VENETOCLAX) — FDA approvalvenetoclax

    Sponsor: ABBVIE. Form: TABLET. Route: ORAL

    full page →venetoclax →fda approvals ↗
    ›Dec 20, 2017approval3148d agoIMBRUVICA (IBRUTINIB) — FDA approvalAbbVie Inc.

    Sponsor: PHARMACYCLICS LLC. Form: CAPSULE. Route: ORAL

    full page →fda approvals ↗
    ›Dec 20, 2017approval3148d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

    Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 20, 2017approval3148d agoICLUSIG (PONATINIB HYDROCHLORIDE) — FDA approvalTakeda Pharmaceuticals USA Inc

    Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    3142d ago
    DESIPRAMINE HYDROCHLORIDE — FDA approvalDESIPRAMINE HYDROCHLORIDE

    Sponsor: INGENUS PHARMS LLC. Form: TABLET. Route: ORAL

    full page →DESIPRAMINE HYDROCHLORIDE →fda approvals ↗
    ›Dec 26, 2017approval3142d agoNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (ETHINYL ESTRADIOL) — FDA approvalNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

    Sponsor: GLENMARK PHARMS LTD. Form: TABLET. Route: ORAL

    full page →NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE →fda approvals ↗
    ›Dec 27, 2017approval3141d agoGABAPENTIN — FDA approvalSciegen Pharmaceuticals Inc

    Sponsor: SCIEGEN PHARMS. Form: TABLET. Route: ORAL

    full page →fda approvals ↗
    ›Dec 29, 2017approval3139d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

    Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Dec 29, 2017approval3139d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

    Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    ›Dec 29, 2017approval3139d agoLAMOTRIGINE — FDA approvalLAMOTRIGINE

    Sponsor: ALEMBIC. Form: TABLET, FOR SUSPENSION. Route: ORAL

    full page →LAMOTRIGINE →fda approvals ↗
    $IGC0.2670+0.41%
    $SUPN44.63-2.15%
    $AMGN385.16-0.64%
    $LLY1148.84-0.53%
    $ABBV250.94-2.51%
    $AMGN385.16-0.64%
    $PFE25.01+0.40%
    $PFE25.01+0.40%
    $INDV40.10-2.17%
    $ABBV250.94-2.51%
    $EXEL53.03-5.25%
    $IGC0.2670+0.41%
    $BMY65.31+0.69%
    $ABBV250.94-2.51%